1. Field of the Invention
The present invention relates to an introducer device for insertion of a catheter, guide wire and the like into a patient. More particularly, the invention provides an improved introducer device comprising a splittable sheath component wherein the sheath comprises a flared end that significantly facilitates entry of a catheter, guide wire, etc. into the device.
2. Background
Splittable introducer devices have been employed for inserting catheters, guide wires and the like into patients. A typical procedure provides for insertion of a dilator or needle encased within a splittable sheath into the vasculature of a patient. After insertion, the dilator or needle may be removed leaving the sheath protruding from the patient's vein. A diagnostic or therapeutic catheter (e.g. a central venous access catheter or guide wire) or other object such as a capsule is then threaded through the sheath into the patient. The encasing sheath is then longitudinally sheared and removed from the catheter or guide wire and the patient such as by applying opposing force to opposed wings or tabs of the introducer device. See U.S. Pat. Nos. 5,334,157; 5,221,263; 5,141,497; 5,098,392; 4,772,266; and 4,243,050; and WO 97/14456 and WO 97/14468.
It can be quite difficult for the surgeon or other medical personnel to insert a catheter or guide wire into an introducer device, particularly when using a small diameter catheter or guide wire. For example, very small diameter catheter are employed in many applications, such as catheters having a diameter of 0.026 inches or less that are used for insertion into the vasculature of neonatal patients. To introduce such a small, flexible tube into the small bore of the introducer requires that the attending medical personnel to exercise significant manual dexterity.
Certain prior introducer devices have been reported that include a hub or wing portions that contain a conical-type lead-in section that could facilitate entry of a guide wire or catheter into the bore of the device's sheath. In those prior devices, the sheath component is affixed to some point along the longitudinal axis and interior surface of the hub or wing portion(s) of the device. The top proximal end of the sheath necessarily forms a shoulder or flange within the hub or wing portion(s), which flange can inhibit a catheter or guide wire passing through the device, particularly the leading edge of a catheter or guide wire. Such inhibition can cause bending of the catheter or guide wire that requires the ancillary medical device to be removed and then reinserted into the introducer. At a minimum, such inhibition of an ancillary medical device is annoying and inconvenient to the medical personnel.
Thus, it would be desirable to have a new introducer device that facilitates entry of an ancillary medical device such as a catheter, guide wire or the like into the device.